(1) The color additive ferric ammonium ferrocyanide is the blue pigment obtained by oxidizing under acidic conditions with sodium dichromate the acid digested precipitate resulting from mixing solutions of ferrous sulfate and sodium ferrocyanide in the presence of ammonium sulfate. The oxidized product is filtered, washed, and dried. The pigment consists principally of ferric ammonium ferrocyanide with smaller amounts of ferric ferrocyanide and ferric sodium ferrocyanide.

(2) Color additive mixtures for drug use made with ferric ammonium ferrocyanide may contain only those diluents listed in this subpart as safe and suitable for use in color additive mixtures for coloring drugs.

(b)Specifications. Ferric ammonium ferrocyanide shall conform to the following specifications and shall be free of impurities other than those named to the extent that the other impurities may be avoided by good manufacturing practice:

Oxalic acid or its salts, not more than 0.1 percent.

Water soluble matter, not more than 3 percent.

Water soluble cyanide, not more than 10 parts per million.

Volatile matter, not more than 4 percent.

Lead (as Pb), not more than 20 parts per million.

Arsenic (as As), not more than 3 parts per million.

Nickel (as Ni), not more than 200 parts per million.

Cobalt (as Co), not more than 200 parts per million.

Mercury (as Hg), not more than 1 part per million.

Total iron (as Fe corrected for volatile matter), not less than 33 percent and not more than 39 percent.

(c)Uses and restrictions. Ferric ammonium ferrocyanide may be safely used in amounts consistent with good manufacturing practice to color externally applied drugs, including those for use in the area of the eye.

(d)Labeling requirements. The label of the color additive and of any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter.

(e)Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therfore batches thereof are exempt from the certification requirements of section 721(c) of the act.

[42 FR 38562, July 29, 1977, as amended at 44 FR 28322, May 15, 1979]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

The effective date for the final rule published April 11, 2014 (79 FR 20095), is confirmed as May 13, 2014.

21 CFR Part 73

Summary

The Food and Drug Administration (FDA or we) is confirming the effective date of May 13, 2014, for the final rule that appeared in the Federal Register of April 11, 2014, and that amended the color additive regulations to expand the permitted use of spirulina extract made from the dried biomass of the cyanobacteria Arthrospira platensis ( A. platensis ) as a color additive in food.

This rule is effective May 13, 2014. See section X for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing by May 12, 2014.

21 CFR Part 73

Summary

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of spirulina extract as a color additive in food. This action is in response to a petition filed by GNT USA, Inc.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Signature Brands, LLC, proposing that the color additive regulations be amended to provide for the safe use of mica-based pearlescent pigments in egg decorating kits for coloring shell eggs.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Colorcon, Inc., proposing that the color additive regulations be amended to provide for the safe use of spirulina extract as a color additive in coating formulations applied to dietary supplement and drug tablets and capsules.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by EMD Millipore Corp., proposing that the color additive regulations be amended to expand the safe use of mica-based pearlescent pigments in alcoholic beverages to include cordials, liqueurs, cocktails, and certain other alcoholic beverages, and non-alcoholic mixers and mixes.

The effective date for the final rule published April 11, 2014 (79 FR 20095), is confirmed as May 13, 2014.

21 CFR Part 73

Summary

The Food and Drug Administration (FDA or we) is confirming the effective date of May 13, 2014, for the final rule that appeared in the Federal Register of April 11, 2014, and that amended the color additive regulations to expand the permitted use of spirulina extract made from the dried biomass of the cyanobacteria Arthrospira platensis ( A. platensis ) as a color additive in food.

This rule is effective May 13, 2014. See section X for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing by May 12, 2014.

21 CFR Part 73

Summary

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of spirulina extract as a color additive in food. This action is in response to a petition filed by GNT USA, Inc.